510(k) · Cleared
ClearedPowder Free Nitrile Examination Gloves Flock-Lined, Black Color
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shen Wei (Usa), Inc. · LZA Polymer Patient Examination Glove
Cleared on Nov 17, 2016 as substantially equivalent to K070639 (Siam Sempermed Corp., Ltd., 2007) after a 213-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Nov 17, 2016
- Review
- 213 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000323 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK000323 Nitrile Patient Examination Glove (Blue Color) Powder Free, Non…Siam Sempermed Corp., Ltd. · 2000
- 2 generations backK060753 Non-Sterile, Powder Free Nitrile Examination Glove, Blue with…Siam Sempermed Corp., Ltd. · 2006
- 1 generation backK070639 Non-Sterile, Powder-Free Nitrile Examination Glove, Blue with…Siam Sempermed Corp., Ltd. · 2007
- This deviceK161074 Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000323 | Nitrile Patient Examination Glove (Blue Color) Powder Free, Non Sterile | Siam Sempermed Corp., Ltd. | 2000 | — |
| −2 | K060753 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating… | Siam Sempermed Corp., Ltd. | 2006 | — |
| −1 | K070639 | Non-Sterile, Powder-Free Nitrile Examination Glove, Blue with Polymer Coating | Siam Sempermed Corp., Ltd. | 2007 | — |
| 0 (this device) | K161074 | Powder Free Nitrile Examination Gloves Flock-Lined, Black Color | Shen Wei (Usa), Inc. | 2016 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZA device
- #1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070639 | Non-Sterile, Powder-Free Nitrile Examination Glove, Blue with Polymer CoatingSummary page 4…ation: Device Name: Non Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating Company Name: Siam Sempermed Corp. Ltd. 510K Number: K070639 5.0 Description of the Device: Powder Free Nitrile Examination Gloves Flock-Lined, Black Color Non-Sterile, is a dispos… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LZA
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZA
110in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZA
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZA
73in 2025
MAUDE reports naming product code LZA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | 95 | 0 | 7 |
| 2008 | 18 | 97 | 0 | 2 |
| 2009 | 28 | 112 | 0 | 12 |
| 2010 | 31 | 97 | 0 | 12 |
| 2011 | 26 | 122 | 0 | 9 |
| 2012 | 33 | 110 | 0 | 11 |
| 2013 | 20 | 130 | 0 | 10 |
| 2014 | 27 | 197 | 0 | 8 |
| 2015 | 20 | 112 | 1 | 12 |
| 2016 | 30 | 171 | 1 | 25 |
| 2017 | 44 | 124 | 0 | 4 |
| 2018 | 22 | 178 | 0 | 3 |
| 2019 | 25 | 212 | 0 | 21 |
| 2020 | 30 | 101 | 0 | 4 |
| 2021 | 139 | 111 | 0 | 20 |
| 2022 | 146 | 111 | 0 | 19 |
| 2023 | 62 | 92 | 0 | 24 |
| 2024 | 30 | 89 | 0 | 76 |
| 2025 | 24 | 110 | 0 | 73 |
| 2026 | 15 | 103 | 3 | — |
What is it indicated for?
Powder-Free Nitrile Examination Glove Flock-Lined, Black Color is a disposable device intended for medical purpose
that is worn on the examiner’s hand to prevent contamination between patient and examiner. This device is single use
only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161074 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161074: Powder Free Nitrile Examination Gloves Flock-Lined, Black Color.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161074
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026